Skip to contentDe Novo DEN240014
- Device
- ARC-EX System
- Contact
- nathalie gilat
- De Novo number
- DEN240014
- Product code
- SDO
- Regulation
- 890.5851
- Classification name
- transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation
- Decision
- granted (DENG)
- Decision date
- 2024-12-19
- Date received
- 2024-03-28
- Classification advisory
- Physical Medicine
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- SDO
- Device name
- Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation
- 890.5851
- Implant
- N
- Life sustain/support
- N